BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22913938 · Received August 28, 2025

    Report

    Report Number
    2016493-2025-109033
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 2, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 18-JAN-2022 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE DEVICE INVOLVED IN THE INCIDENT, IT WAS DETERMINED THAT THE CUBIE POCKET HAD EXPERIENCED READ, WRITE, OR INVALID CUBIE MEMORY ERRORS. A FIELD SERVICE ENGINEER (FSE) CONFIRMED THE FAILURE THROUGH STORAGE SPACE RECOVERY. AFTER ENCOUNTERING LOGIN ISSUES, ACCESS TO REMOTE SMART SERVICE AND HARDWARE TEST APPLICATION WAS ESTABLISHED. CUBIE STATUS WAS CHECKED, AND THE BACK PANEL WAS REMOVED TO INSPECT THE LEDS. THE STATION WAS POWERED DOWN, THE DRAWER WAS OPENED, AND THE ROW BOARD CABLE WAS DISCONNECTED AND RECONNECTED. AFTER POWERING UP, ONLY THE HELMER FRIDGE WAS VISIBLE IN STORAGE SPACE CONFIGURATIONS. POWER WAS RECYCLED MULTIPLE TIMES, AND COMPONENTS WERE DISCONNECTED AND RECONNECTED. EVENTUALLY, THE MAIN CABINET, AUXILIARY CABINET, AND AUXILIARY TOWER BECAME VISIBLE. AN ERROR WAS FOUND ON THE TOWER, AND THE PYXIS BUS CABLE WAS REPLACED. AFTER REBOOTING, ALL COMPONENTS CAME ONLINE. FUNCTIONALITY WAS TESTED IN HARDWARE TEST APPLICATION AND VERIFIED BY THE CUSTOMER. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES HAS INVALID CUBIE MEMORY ISSUE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES HAS INVALID CUBIE MEMORY ISSUE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520577 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown